Current Trials

Further information regarding clinical research studies approved by the FDA can be found at ClinicalTrials.gov. For interest in being a healthy subject volunteer please visit Indiana Clinical and Translational Institute or call 317.278.2176.

Indiana University Health Methodist Hospital

IRB # –Study Title PI/Dept Age/Condition Purpose

1509255354 – Phase III efficacy and safety study of AB103 in the treatment of patients with necrotizing soft tissue infections

Reed Emergency Medicine

≥ 12 yrs
Necrotizing soft tissue infections, necrotizing fascilitis, fournier's gangrene

The primary hypothesis of this study is that in addition to standard of care treatment, AB103 will demonstrate a clinically significant treatment benefit over placebo.

1411838656 – Reversal of dabigatran anticoagulant effect with idarucizumab

Reed Emergency Medicine

≥ 18 yrs
Hemorrhage

To evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

1506863146 – Prospective observational study to compare performance characteristics of the Arctic Sun system versus wrap cooling for therapeutic hypothermia in sudden cardiac arrest patients

Ellender Emergency Medicine

≥ 18 yrs
Sudden cardiac arrest

To compare the Arctic Sun temperature management system with wrap cooling for therapeutic hypothermia

1510320657 – Clinical study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation (Soprano)

Caccamo
Cardiology

≥ 50 yrs
Pulmonary hypertension

To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation

1508589568 – Understanding outcomes with the EMBLEM™ S-ICD in primary prevention patients with low ejection fraction

Bhakta Cardiology

≥ 21 yrs
Ventricular fibrillation, ventricular tachycardia, low cardiac output

To determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections receiving standard of care therapy.

1209009662 – A U.S. post-approval study of the PROMUS element™ plus everolimus-eluting platinum chromium coronary stent system

Fisch
Cardiology

Coronary artery disease

To observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. 

1209009610 – The PARTNER II trial: Placement of AoRTic TraNscathetER valves

Sinha Cardiology

Symptomatic severe aortic stenosis

To determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems, which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

1401321015 – Study of human plasma-derived alpha1-proteinase inhibitor in subjects with new-onset type 1 diabetes mellitus

Mariash
Medicine, endocrinology

6 yrs to 35 yrs
Diabetes mellitus, type 1

To evaluate the safety and efficacy of 4 dosing regimens of human plasma-derived alpha1-PI in T1DM.

1403636387 – OPsumit USers Registry

Harvey Medicine- pulmonary, allergy, critical care & occupational medicine

Pulmonary arterial hypertension

To characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

1503046583 – PORtopulmonary Hypertension Treatment wIth maCitentan ─ a randOmized Clinical Trial

Lahm
Medicine- pulmonary, allergy, critical care & occupational medicine

≥ 18 yrs
Portopulmonary hypertension

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension

1506963342 – Phase 3 safety and efficacy study of ART-123 in subjects with severe sepsis and coagulopathy

Kapoor Medicine- pulmonary, allergy, critical care & occupational medicine

≥ 18 yrs
Severe sepsis, coagulopathy

To evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.

1508809977 – Presatovir in lung transplant (LT) recipients with respiratory syncytial virus (RSV) infection

Hage
Medicine- pulmonary, allergy, critical care & occupational medicine

≥ 18 yrs
Respiratory syncytial virus (RSV)

To evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

1105005473 – Evaluation of reactivity of mononuclear cells to collagen V in lung transpant patients

Geraci Medicine- pulmonary, allergy, critical care & occupational medicine

 

To evaluate reactivity of mononuclear cells to collagen V in lung transpant patients

1509136583 – A phase 3 study of LJPC-501 in patients with catecholamine-resistant hypotension

Naum
Medicine- pulmonary, allergy, critical care & occupational medicine

≥ 18 yrs
Catecholamine-resistant hypotension (CRH

This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers in the United States.

1310454500 – Beraprost-314d added-on to Tyvaso® (BEAT)

Harvey Medicine- pulmonary, allergy, critical care & occupational medicine

18 yrs to 80 yrs
Pulmonary arterial hypertension

To assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension.

1010002276 – Protocol for the collection and transfer of cystic fibrosis lungs for research purposes

Roe
Medicine- pulmonary, allergy, critical care & occupational medicine

 

 

1411663529 – National biological sample and data repository for pulmonary arterial hypertension

Lahm
Medicine- pulmonary, allergy, critical care & occupational medicine

 

 

1410508609 – Donor smoke exposure and the relationship to primary graft dysfunction

Hage
Medicine- pulmonary, allergy, critical care & occupational medicine

 

 

1602009422 – Safety and efficacy of inhaled treprostinil in adult PH with ILD Including CPFE

Harvey Medicine- pulmonary, allergy, critical care & occupational medicine

18 yrs to 79 yrs
Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema

To evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE)

An open-label extension study of inhaled treprostinil in subjects with pulmonary hypertension due to parenchymal lung disease

Harvey Medicine- pulmonary, allergy, critical care & occupational medicine

≥ 18 yrs
Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema

To evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 75 clinical trial centers.

1412113692 – Extracorporeal photopheresis for the management of progressive bronchiolitis obliterans syndrome in medicare-eligible recipients of lung allografts

Hage
Medicine- pulmonary, allergy, critical care & occupational medicine

≥ 18 yrs
Bronchiolitis obliterans syndrome (BOS)

To determine if Extracorporeal Photopheresis (ECP) is effective in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation.

1411911137 – The INSPIRE study: probable benefit of the neuro- spinal scaffold for treatment of AIS a thoracic acute spinal cord injury

Horn Neurological Surgery

16 yrs to 70 yrs
Traumatic thoracic acute spinal cord injury

To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury.

1309231618 – Zenith® TX2® low profile TAA endovascular graft clinical study

Corvera Surgery

≥ 18 yrs
Aortic aneurysm, penetrating ulcer, vascular disease

To evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

1209009615 – Clinical investigation of the cook formula™ 535 iIliac balloon-expandable stent

Fajardo Surgery

≥ 18 yrs
Aorto-iliac aneurysms, illiac aneurysms

To study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

1408941961 – Prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot® Polysaccharide Hemostatic System

Coffey
Surgery

≥ 22 yrs
Blood loss, surgical

To evaluate the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.

1411712195 – A prospective, single arm, multi-center clinical study in collaboration with the interagency registry for mechanically assisted circulatory support (INTERMACS®) to evaluate the thoracotomy implant technique of the HeartWare HVAD® System in patients with advanced heart failure. Hashmi Surgery

≥ 19 yrs
Left-sided heart failure

To evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD® System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) protocol and database.
1309182139 – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) Wozniak Surgery

≥ 18 yrs
Chronic heart failure

To evaluate the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management.
1011003773 – A clinical trial to evaluate the HeartWare® Ventricular Assist System Wozniak Surgery

≥ 18 yrs
Chronic heart failure

To determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
1212010179 – Post-approval study on patients who received a HeartWare HVAD® during IDE trials Wozniak Surgery

≥ 18 yrs
Heart failure

Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
1302010599 – Novel lung trial: normothermic ex vivo lung perfusion (Evlp) as an assessment of extended/marginal donor lungs Wozniak Surgery

≥ 18 yrs
Lung transplant

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.
1506100229 – SynCardia 50cc temporary total artificial heart (TAH-t) as a bridge to transplant Wang
Surgery

≥ 10 yrs
Heart failure, right-sided, cardiac failure, heart failure, left-sided

To evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.
1510320657 – International trial to evaluate the safety and effectiveness of the portable Organ Care System (OCS™) heart for preserving and assessing expanded criteria donor hearts for transplantation (EXPAND Heart Trial) Wang
Surgery

≥ 18 yrs
Heart transplant

To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation.
1306011578 – International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation Wang
Surgery

≥ 18 yrs
Lung presevation

To compare preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).